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NCT03567525 · ClinicalTrials.gov registry record · NA
Peritoneal Iliac Flap and Lymphocele Formation After Robotic Radical Prostatectomy
A NA study, sponsored by Hartford Hospital.
- Completed
- Registry status
- NA
- Development phase
- 225
- Enrollment target
NCT03567525 is a NA study that has completed, run by Hartford Hospital. The registered enrollment target is 225 participants.
The verdict
NCT03567525, a NA study, has completed, sponsored by Hartford Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 225 participants
- Enrollment target
Study Summary
Lymphoceles are a potentially serious complication of radical prostatectomy (RP) with pelvic lymph node dissection. They are associated with abdominal pain, urinary tract symptoms, fever, lower extremity swelling and deep vein thrombosis. They can be severe enough to necessitate intervention in 5% of patients after RRP with PLND, with sequela that could include infection and nerve damage. Studies evaluating strategies to preclude lymphocele formation after RP have included comparisons of the use of titanium clips vs bipolar coagulation to seal lymphatic vessels during pelvic lymph node dissection. In a recent prospective randomized trial comparing these approaches, no differences were observed in the rates of lymphocele formation as detected by ultrasound. There is a need to continue to test potential strategies to minimize the formation of lymphoceles after RRP. Creation of a peritoneal iliac flap is one approach has potential towards this end. At the Lahey Hospital and Medical Center in Burlington, MA surgeons routinely fold the bladder into a peritoneal flap to overlay the area of extended lymphadenectomy. It is thought that this method prevents the formation of lymphoceles because the flap creates a window, which allows drainage of the lymph fluid into the peritoneal cavity to be reabsorbed. While the Lahey study supports the safety and effectiveness of the peritoneal flap approach, the procedure has never been evaluated through a randomized prospective trial and the practice is certainly not standard of care. We therefore propose a randomized, prospective clinical trial to be conducted in the Hartford Hospital Urology Department to examine the effectiveness of a peritoneal iliac flap on the formation of lymphoceles after RRP with pelvic lymph node dissection. Hypotheses: 1. We hypothesize that, at 3 months after RP, rates of lymphocele formation (symptomatic and asymptomatic lymphoceles) will be significantly lower in patients who have pelvic lymph node diss
Interventions
- PROCEDURE lymph node dissection using the peritoneal iliac flap approach to seal lymphatic vessels
- PROCEDURE Standard surgical approach
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 225 participants |
| Start Date | 2018-09-14 |
| Est. Completion | 2022-07-08 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03567525
The ClinicalTrials.gov registry entry for NCT03567525 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 225 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hartford Hospital, which has 75 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which lymph node dissection using the peritoneal iliac flap approach to seal lymphatic vessels is the first listed.
NCT03567525 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03567525 about?
NCT03567525 is a clinical study titled "Peritoneal Iliac Flap and Lymphocele Formation After Robotic Radical Prostatectomy". Lymphoceles are a potentially serious complication of radical prostatectomy (RP) with pelvic lymph node dissection. They are associated with abdominal pain, urinary tract symptoms, fever, lower extremity swelling and deep vein thrombosis. They can be severe enough to necessitate intervention in 5% o...
What is the current status of trial NCT03567525?
This trial is currently completed. It is a NA study. The enrollment target is 225 participants. The study started on 2018-09-14. Estimated completion is 2022-07-08.
What interventions are being tested in trial NCT03567525?
The interventions under investigation include: lymph node dissection using the peritoneal iliac flap approach to seal lymphatic vessels (PROCEDURE), Standard surgical approach (PROCEDURE).
Who is sponsoring clinical trial NCT03567525?
This trial is sponsored by Hartford Hospital, which has 75 total clinical trials registered on ClinicalTrials.gov.
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